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NCT Number: NCT07493538

MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.

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Key information

Conditions

AML Acute Leukemia Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MDS Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

2 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 2-75 years of age
  • ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (< 16 years) with appropriate organ criteria as below (in other inclusion criteria)
  • 5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor
  • adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT <5X ULN) and renal function (creatinine <2.0)
  • absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
  • DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement

Exclusion criteria

  • Pregnant or breastfeeding
  • Evidence of untreated/uncontrolled HIV infection
  • Untreated active serious infection
  • Active CNS malignancy
  • CML in blast crisis not in a complete remission by abnormal blast count.
  • Less than 3 months since prior myeloablative transplant

Treatment and study plan

Treosulfan

Drug

12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.

Fludarabine

Drug

Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .

Total Body Irradiation

Radiation

TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.

Other names: TBI

Tacrolimus

Drug

Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL.

Mycophenolate mofetil

Drug

All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.

Other names: MMF

Cyclophosphamid

Drug

Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).

Stem Cell Infusion

Biological

Given on day 0.

Primary outcomes

  1. Overall Survival

    Time frame: Day 100

    Evaluate rates of overall survival at 100 days after transplant.

Secondary outcomes

  1. Transplant Related Mortality

    Time frame: Day 100 and 1 year

    ● Estimate transplant related mortality (TRM) at 100 days and 1 year with this conditioning and GVHD prophylaxis combination

  2. Overall Survival

    Time frame: 1 and 2 years

    Estimate overall survival at 1 and 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Graham, MD

CONTACT

[email protected]

612-625-3051

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
Mar 25, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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